Europeans have long looked at US AIDS activism with a
mixture of awe and concern. Awe at its power to move the
agenda forward, and concern at its introspective focus.
As with so many features of US life, it is introspective
because America is self-contained in its splendid
isolation, while Europeans are becoming increasingly
used to seeing their lives in a multinational context.

Public debate in Europe is currently dominated by one
topic: closer economic and political union. The European
Union will grow northward and eastward to embrace
Scandinavia, the Baltic states, and central eastern
Europe during the next ten years. How can Europeans
reconcile the seemingly autonomous dynamic of
globalization and commercial harmonization with the
increasing diversification of Europe? Are we heading for
a United States of Europe, as English statesmen fear and
German leaders appear to desire fervently, or another
Holy Roman Empire, its lingua franca English and its
governance a patchwork of states with many proud
histories and many conflicting customs, held together
only by fear of invasion from outside?

Across the EU

Bringing together European activists in the field of
AIDS has been a slow process, but the growing
realization that Europe is becoming an interdependent
web is forcing activists to move quickly to develop a
pan-European perspective. The shift to a pan-European
drug approval process and the tendency of companies to
conduct compassionate release operations at a European
level has led to closer contact among treatment
advocates across the European Union, primarily through
the vehicle of the European AIDS Treatment Group (EATG).

Following criticisms that the Second International
Congress on Drug Therapy in HIV Infection (Glasgow,
1994) lacked community input, chairman Professor Ian
Weller was eager to ensure that European activists got
the chance to participate in the Third Congress in
Birmingham, and to hold a satellite meeting. The result
was a session entitled "Productive Partnerships,"
intended to highlight the ways in which European
activists have worked with clinicians, researchers,
regulators, and public health officials in the European
Union countries.

The European AIDS Treatment Group was founded in
1991, and now comprises over 60 activists from 17
European countries. France, Germany, and the UK are most
heavily represented in the group, but one of the group's
priorities for 1997 is the development of treatment
activists in Spain, Portugal, Italy, and Greece, and a
southern European activist training is planned for April
in Naples.

The group's current focus is shortening the gap
between scientific approval and marketing approval in
the European Union's drug licensing procedure. The group
also wants to see clearer drug approval guidelines in
Europe, says executive director Arjen Broekhuizen, a
political journalist from The Netherlands. "At the
moment it is unclear to everyone -- industry, regulators
and the community -- what requirements a company has to
meet in order to get approval."

At a European level, activists are working hard to
form strategies for developing trials. Raffi Babakhanian
of the UK-based AIDS Treatment Project (ATP) reported on
the EATG's progress in bringing together researchers,
industry, and regulators to discuss whether they could
cooperate in the development of strategy trials. He
noted that as "honest brokers" activists are well placed
to bring together the interested parties, as ATP and
EATG did at a meeting in London last June. The groups
intend to organize a similar meeting during 1997 and
hope to work closely with the Keystone Group in the US
on the international coordination of strategic research
in HIV drug therapy.

A European minimum standard of care is another focus,
and the group plans to lobby at the national and
European Union levels with governments, professional
associations, and doctors to win agreement on a common
standard for HIV care throughout the EU. Huge
disparities exist between standards in countries such as
France, Germany, and The Netherlands on the one hand,
and those in Spain, Greece, and Italy on the other, says
Broekhuizen. Much of the rest of the EU lies somewhere
between these two poles, he says.

Rob Camp of Federación por Informaciones
Tratamientos (FIT), the Spanish treatment advocacy
group, described some of the problems Spain faces. Viral
load testing is still not available except as a research
tool, and earlier this year 62 Spanish nongovernmental
AIDS organizations signed on to a demand for viral load
testing to be fully funded. They are still waiting, just
as Spaniards were still waiting at the time of the
Birmingham meeting for reimbursement approval from the
Spanish health ministry for indinavir, saquinavir, and
3TC.

Such lassitude is all the more surprising when one
learns that Spain is the worst-affected country in
Europe. With 191 cases per million inhabitants, Spain is
the only European country with an epidemic that matches
that of the US in severity. The major difference between
Spain and the US is that 65 percent of Spanish AIDS
diagnoses occur among injecting drug users. Early
treatment is still relatively rare in Spain; the median
CD4+ count at diagnosis, according to a recent study,
was 181. FIT estimates that less than 5000 people with
HIV have access to triple combination therapy through
major clinics. The standard of care for the others is
likely to remain monotherapy, or two drugs at best,
until physician education has advanced considerably.

To expedite this advance, FIT publishes a newsletter
and a document which outlines the standard of care
devised by the International AIDS Society. But these
publications can reach only 4500 people, a drop in the
ocean in a country where approximately 135,000 people
have already been diagnosed HIV-positive.

The experience of French activists was described by
François Houyez of ACT UP Paris. Since 1993
France's major AIDS organizations concerned with
education and advocacy have been working together in an
organization called TRT-5 (Traitements et Recherche
Therapeutique Cinq). The organization represents the
combined positions of Action Traitements, AIDES,
Arcat-SIDA, ACT UP Paris, Sol en Si, and Vaincre le SIDA
(the national fundraising organization). Activists saw
the need to combine, said Houyez, to counter the divide
and rule tactics being pursued by government and some
pharmaceutical companies. Since 1993, TRT-5 has been
spectacularly successful in developing productive
partnerships with government, researchers, and industry.
TRT-5's pressure was instrumental in securing early
access and reimbursement for indinavir and ritonavir in
France, and the coalition has worked closely with the
French regulatory agency to ensure speedy access to new
treatments. TRT-5 is also represented on French research
committees. In this respect France is not unique, but
the degree of formal consultation is.

Dutch reimbursement victory

Another success story from Europe, as reported in
September's "Inside the EU" column here, is the
achievement of Dutch AIDS organizations in persuading
Holland's Health Minister, Dr Els Borst, to reverse her
hardline opposition to reimbursement for anti-HIV drugs
approved without lengthy clinical endpoint trials. She
had justified her stance by saying that she wished to
avoid "another thalidomide." Historically, The
Netherlands has long had a restrictive attitude towards
the licensing of new therapies, an attitude that
reflects the county's efforts to keep prescribing costs
down. As I reported in the May 1996 Journal, the
Dutch had adopted a system that clustered drug prices by
disease category and then reimbursed only for the
cheapest products, regardless of efficacy. This approach
was intended to force companies to "bid down" drug
prices, and costs were further controlled by placing a
temporary moratorium on new drugs which appeared to be
"me too" products. This mechanism initially blocked
access to ddC in The Netherlands, although the
restriction was later relaxed. These policies appeared
to block any prospect of combination therapy becoming
the standard of care in The Netherlands, despite
powerful support for the approach among patient
advocates and leading physicians.

The Dutch HIV Association had taken a strong position
in support of dual combination treatment even in the
months before the 1994 Glasgow meeting marked the advent
of the ZDV/3TC era. The radicalism of this position
stands in stark contrast to that of many other European
countries, where, until very recently, AIDS
organizations have been much more reticent about
committing themselves to advocacy for particular
treatment strategies. The Dutch confidence was no doubt
bolstered by the proximity of Joep Lange, MD, PhD, who
played an important role in lobbying the Dutch
government. "In the days when it was still forbidden to
speak of hope for PWAs," said Nico Hollander, "Joep
Lange spoke out in support of wider access to protease
inhibitors, and insisted that these drugs should be seen
as part of a potential cure for AIDS."

Dutch efforts were also enhanced by the clout of Dick
Daes, former Health Minister and now head of the Dutch
AIDS Fund. Activists briefed all Dutch MPs and ministers
in early 1996, and launched a media campaign
highlighting the plight of PWAs who could not get access
to drugs despite their approval in the United States.
One of these was Nico Hollander's partner, who was
fighting to get access to ritonavir, and he was among
the PWAs who personally wrote to Borst appealing for a
more liberal reimbursement policy.

In the spring of 1996, Borst relented, and promised
that henceforth any drug given a favorable review by the
EMEA's scientific advisory committee would become
immediately reimbursable in The Netherlands, even though
it might not receive marketing authorization from the
European Commission for a further three to four months.
This decision ensured that Dutch patients would have
unrestricted access to new drugs before almost
two-thirds of other patients in the European Union. Only
German and Austrian patients enjoy similar opportunities
prior to an EU marketing authorization.

The Dutch experience shows the importance of
compassion in forming public policy on AIDS. That may be
an obvious statement, yet it is becoming clear that the
ethical calculus of public health in some European
countries is becoming increasingly subordinate to the
dictates of fiscal probity.

The Dutch experience also shows the importance of
alliances between national AIDS organizations. Some
European countries have more sophisticated national
coalitions than others, and some activists at the
Birmingham satellite meeting took this as a sign that
some countries have profound internal problems when it
comes to creating domestic alliances between AIDS
organizations. But the trajectory of activism has
differed from one country to another, and there is, as
British writer Simon Watney once pointed out, a natural
history of treatment activism in just the same way as
there is a natural history of HIV disease, and the rate
of presentation of activism in different countries has a
lot to do with medical practice and cultural
assumptions. Didier Lestrade of ACT UP Paris noted,
apparently in ignorance of the implications of his
statement, that the Dutch accomplished everything they
did without the need to resort to direct action (for
which read the ACT UP Paris model). Similarly,
educational strategies have evolved very differently in
European countries. In France and Germany national
networks of AIDS organizations exist. In the UK and
Spain they do not. This immediately sets up a situation
where AIDS organizations are inclined to compete rather
than cooperate.

But it would be unwise of activists' adversaries (or
partners, depending on context) to assume that these
differences make it easy to play off countries one
against the other, or to pick off organizations less
favorable to a pharmaceutical agenda. There is a
remarkable degree of consensus among European activists
on the big issues, such as the design of compassionate
release schemes and the need for accelerated approval
mechanisms, which has been absent in the recent history
of US treatment activism. What has been lacking until
very recently is any productive partnership with US
activists, who have not understood the relevance of
European developments for their own backyard.

This article was provided by International Association of Physicians in AIDS Care. It is a part of the publication Journal of the International Association of Physicians in AIDS Care.
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